The U.S. Pharmacopeial Convention (USP) Senior Technical Advisor PQMPlus in Kigali, Rwanda
Summary of the Position
The Senior Technical Advisor, Regulatory Systems & Quality Management Systems Strengthening (STA- RSS/QMS) will have expert skills in key pharmaceutical regulatory functions including Post-Marketing Surveillance (PMS), Quality Management Systems (QMS) Product Evaluation and Registration, Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) among others. The STA RSS/QMS will provide technical assistance to the Rwanda FDA and to the Ministry of Health to build their capacity to regulate pharmaceutical products in Rwanda.
The STA-RSS/QMS will have expert knowledge in Post-Marketing Surveillance (PMS), Quality Management Systems (QMS) Product Evaluation and Registration, Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). The STA-RSS/QMS will be knowledgeable about quality testing methods and techniques and compliance requirements of national laboratories. He/she must demonstrate understanding of the functioning of drug testing laboratories that lead to ensuring that tested samples meet the set standards of quality, safety, and efficacy. The STA will be a technical resource to the Rwanda FDA in updating key Quality Management System (QMS) documents; and to strengthen internal capacity for compendial testing techniques. He/she will help the Rwanda FDA to identify staff training requirements to meet the quality standards and develop and monitor corrective measures towards strengthening the regulatory capacity of the Rwanda FDA.
The selected candidate will work with other PQM+ team members to assist Rwanda FDA to implement relevant actions listed in the institutional development plan (IDP) of the authority, focusing on the QC laboratory, to assist the Rwanda FDA attain the WHO-Global Benchmarking Tool (WHO-GBT) Maturity Level 3. He/she will provide technical oversight of the PMS and QMS related components of the PQM+’s objective of improving country and regional regulatory systems to assure the quality of medical products in the public and private sectors.
Roles and Responsibilities
• Provide technical oversight of activities to support the regulatory functions of Rwanda FDA
• Work with Rwanda FDA to implement relevant actions listed in the institutional development plan (IDP) of the authority, focusing on the QC laboratory, to assist the Rwanda FDA attain the WHO-Global Benchmarking Tool (WHO-GBT) Maturity Level 3.
• Implements PQM+ technical activities under the guidance of the regional and US Rockville-based technical teams.
• Provide technical assistance for the planned activities to support the Rwanda FDA’s drug Quality Control (QC) laboratory
• Propose, design, and implement interventions aimed at strengthening the PMS, QMS and QC systems including the development and implementation of protocols, guidelines, procedures, and other relevant tools
• Provide technical leadership and support to improve efficiency, effectiveness, and sustainability of PMS and QC laboratory activities
• Work closely with the Rwanda FDA to support development and deployment of lab related strategies towards improvement of national regulatory systems
• Actively contribute to annual programmatic and resource planning process and development of quarterly and annual reports
• Support development of country work plans and budgets.
• Collect and report program data and indicators; documents and translates program information; and helps in coordinating in-country program logistics for implementation of workplan activities.
• Lead and manages other PQM+ local staff and consultants in Rwanda
• Performs other duties as assigned by the program manager
• Bachelor’s degree in pharmaceutical sciences
• At least twelve (12) years’ hands-on experience working in pharmaceutical regulation, quality management systems or pharmaceutical quality control
• At least three (3) years managing staff
• Results driven with demonstrated successful outcomes
• Experience in managing and leading technical teams
• Willingness to travel 25% of the time
• Master’s degree in pharmaceutical sciences/pharmaceutical quality assurance and quality control of medicines preferred
• Post-qualification training and implementation in pharmaceutical quality management systems, preferred.
• Strong technical writing and communication skills and fluent in spoken and written English language.
• Ability to build relationships and interact effectively with technical experts, other partners, and donor agencies.
• Experience working with USAID projects preferred.
• Must possess ability to work independently and handle multiple priorities in a fast-paced environment
• Skills in training and workshop facilitation desired
• Demonstratable highest degree of ethics and integrity.
• Excellent interpersonal, leadership and organizational skills with strong attention to detail.
Senior Technical Officer
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The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Technical Programs
Job Type Full-Time